San Diego’s BioTheranostics Gears Up to Sell Test That Predicts Breast Cancer Relapse

One big question women often have after getting diagnosed with breast cancer is whether their first round of treatment is really going to work, or whether they need more aggressive therapy to prevent a relapse. Another big one is whether aggressive treatment is likely to work. Now a little diagnostic company from San Diego, called bioTheranostics, has built a test that it says can help doctors and patients better answer these questions.

Researchers presented data over this weekend at the San Antonio Breast Cancer Symposium from several big clinical trials highlighting a new test from bioTheranostics, a San Diego unit of France-based bioMérieux. The bioTheranostics method passed an important test when researchers found that patients who were classified as “low-risk” were, in fact, found to have only a 4 percent chance of recurrence after a decade of follow-up. Another study found that the bioTheranostics test was able to predict which patients had a three-fold greater likelihood of benefitting from a standard aromatase inhibitor therapy from Novartis, called letrozole (Femara).

The evidence is compelling enough that bioTheranostics says it is now ready to gear up and start commercializing its molecular test, which it calls the Theros Breast Cancer Index (BCI). The company, which has about 40 employees in San Diego, runs a central lab that analyzes the extend to which two biomarkers found in tumor biopsies are turned on or off. This is supposed to be useful for breast cancer patients whose disease is fuelled by estrogen, but which hasn’t yet spread to the women’s lymph nodes. This type of disease, known as estrogen-receptor positive/lymph node negative breast cancer, is found in 60 to 70 percent of all patients. About 192,000 women are diagnosed with various forms of breast cancer each year, according to the American Cancer Society.

BioTheranostics expects to start commercializing its test actively in 2010, based on the data being presented this weekend in San Antonio, Ding says. The company’s assay will be priced between $3,000 and $4,000 apiece, depending on how negotiations go with health insurers. Using the conservative estimate of price, and assuming bioTheranostics can sell its test … Next Page »